Specifications
| Specification | Product or material | Test | Acceptance criteria | Method | Status |
|---|---|---|---|---|---|
| SPEC-MF500 v7 | Metformin HCl 500 mg tablets | Assay (HPLC) | 95.0 to 105.0 % of label claim | QCM-112 v4 | Effective |
| SPEC-MF500 v7 | Metformin HCl 500 mg tablets | Water (KF) | NMT 0.5 % w/w | QCM-031 v2 | Effective |
| SPEC-MF500 v7 | Metformin HCl 500 mg tablets | Dissolution, 30 min | Q NLT 80 % | QCM-114 v3 | Effective |
| SPEC-AM005 v4 | Amlodipine 5 mg tablets | Related substances | Any impurity NMT 0.2 % | QCM-140 v2 | Effective |
| SPEC-AM005 v4 | Amlodipine 5 mg tablets | Dissolution, 30 min | Q NLT 80 % | QCM-141 v1 | Effective |
| SPEC-PW001 v3 | Purified water | Total organic carbon | NMT 500 ppb | QCM-201 v5 | Effective |
| SPEC-MF500 v6 | Metformin HCl 500 mg tablets | Assay (HPLC) | 95.0 to 105.0 % of label claim | QCM-112 v3 | Superseded |
A new version takes effect on approval. Samples logged earlier keep the version they were logged against.